Details for New Drug Application (NDA): 040209
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NDA 040209 describes TRIFLUOPERAZINE HYDROCHLORIDE, which is a drug marketed by Chartwell Rx, Wockhardt, Athem, Duramed Pharms Barr, Ivax Pharms, Mylan, Sandoz, and Watson Labs, and is included in twenty NDAs. It is available from five suppliers. Additional details are available on the TRIFLUOPERAZINE HYDROCHLORIDE profile page.
The generic ingredient in TRIFLUOPERAZINE HYDROCHLORIDE is trifluoperazine hydrochloride. There are ten drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the trifluoperazine hydrochloride profile page.
The generic ingredient in TRIFLUOPERAZINE HYDROCHLORIDE is trifluoperazine hydrochloride. There are ten drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the trifluoperazine hydrochloride profile page.
Summary for 040209
| Tradename: | TRIFLUOPERAZINE HYDROCHLORIDE |
| Applicant: | Mylan |
| Ingredient: | trifluoperazine hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 040209
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRIFLUOPERAZINE HYDROCHLORIDE | trifluoperazine hydrochloride | TABLET;ORAL | 040209 | ANDA | Mylan Pharmaceuticals Inc. | 0378-2401 | 0378-2401-01 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2401-01) |
| TRIFLUOPERAZINE HYDROCHLORIDE | trifluoperazine hydrochloride | TABLET;ORAL | 040209 | ANDA | Mylan Pharmaceuticals Inc. | 0378-2402 | 0378-2402-01 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2402-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 1MG BASE | ||||
| Approval Date: | Jul 7, 1997 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 2MG BASE | ||||
| Approval Date: | Jul 7, 1997 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | Jul 7, 1997 | TE: | AB | RLD: | No | ||||
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